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Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

Information source: Universidad de Granada
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibromyalgia

Intervention: trazodone, pregabalin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Universidad de Granada

Official(s) and/or principal investigator(s):
Elena P Calandre, MD, Principal Investigator, Affiliation: Universidad de Granada


The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.

Clinical Details

Official title: Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire

Secondary outcome:

Change from baseline to endpoint in the scores of the Pittsburgh Sleep Quality Inventory, the Brief Pain Inventory, the Beck Depression Inventory, and the Hospital Anxiety and Depression Scale

Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- patients diagnosed of fibromyalgia according to the American College of Rheumatology


- written, informed consent

- able to understand and comply with the requirements of the study

Exclusion Criteria:

- pregnancy or breastfeeding

- unwillingness to discontinue other prescribed medications before entering in the


- patients who had previously received trazodone without improvement or who did not

tolerate the drug

- patients who had previously received pregabalin without improvement or who did not

tolerate the drug (only for the phase II of the study)

Locations and Contacts

Instituto de Neurociencias, Granada 18012, Spain
Additional Information

Web page of the Institute of Neuroscience of the University of Granada

Starting date: April 2008
Last updated: December 1, 2014

Page last updated: August 23, 2015

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